Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated with the presence of EGFR mutations in exons 18, 19 and 21, in this population

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC

• No previous therapy for advanced/metastatic NSCLC is allowed

• age >18 years

• bidimensionally measurable disease

• non-smokers (or ex-smokers with less than 5 pack-years smoking history)

• adenocarcinoma histology

• performance status (WHO) 0-3

• adequate liver (serum bilirubin <1.5 times the upper normal limit (UNL); AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function

• previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields

• patient able to take oral medication

• tissue sample for tumour mutational analysis is required

Exclusion Criteria:

• serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation

• active infection

• history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)

• malnutrition (loss of ≥ 20% of the original body weight)

• performance status: 4

• psychiatric illness or social situation that would preclude study compliance

• pregnant or lactating women